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Taking people in ChinaPhase 2

Tests avapritinib in children with relapsed or refractory KIT-mutated leukemia

Tests avapritinib in children up to 18 with returned or resistant leukemia.

Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation

Key facts

Where
Changsha, Guangzhou, Hefei, Jinan, Kaifeng, Nanning, Shanghai, Suzhou, Xuzhou, and Zhengzhou, ChinaSee the 12 sites
Phase
Phase 2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers under 18 with a type of acute myeloid leukemia (CBF-AML) that has come back or did not respond to treatment, and who have a KIT mutation.

Age
Under 18 years
Sex
All sexes can join.
Disease stage
Acute myeloid leukemia with t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11. Refractory: no CR or CRi after induction therapy. Relapsed: remission after consolidation or transplant, then the fusion gene turned positive on FISH or leukemia was found outside the bone marrow.
Earlier treatment
Must not have had avapritinib before. Must not be taking other targeted AML drugs such as dasatinib, sorafenib, gilteritinib or venetoclax at the same time.
Biomarker or test result
KIT mutation, plus t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11.

Main reasons for not taking part

  • Active uncontrolled infection (bacterial, fungal or viral)
  • Serious organ disease, such as heart attack, chronic heart failure, or decompensated liver or kidney dysfunction
  • Another cancer that needs treatment
  • Already in another interventional clinical study
  • Prior treatment with avapritinib

Read by machine on 12 November 2026.

Where in China

  • Third Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Minghua Yang, MDNot yet recruiting
  • Xiangya Hospital Central South UniversityChangsha, ChinaContact: Liangchun Yang, MD,PhDNot yet recruiting
  • Guangzhou Women and Children Medical CenterGuangzhou, ChinaContact: Hua Jiang, MD, PhDNot yet recruiting
  • First Affiliated Hospital Of University of Science and Technology of ChinaHefei, ChinaContact: Chun Li, MD,PhDNot yet recruiting
  • The Second Hospital of Anhui Medical UniversityHefei, ChinaContact: Ninglin Wang, MDNot yet recruiting
  • Qilu Hospital of Shandong UniversityJinan, ChinaContact: Xiuli Ju, MD,PhDNot yet recruiting
  • Kaifeng Children's HospitalKaifeng, ChinaContact: Jixia Luo, MDNot yet recruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaContact: Ning Liao, MDNot yet recruiting
  • Children's Hospital Of Fudan UniversityShanghai, ChinaContact: Xiaowen Zhai, MD, PhDNot yet recruiting
  • Children's Hospital of Soochow UniversitySuzhou, ChinaContact: Shaoyan Hu, MD, PhDTaking people
  • Xuzhou Children's HospitalXuzhou, ChinaContact: Qi An, MDNot yet recruiting
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Yufeng Liu, MD,PhDNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Children's Hospital of Soochow University
Trial code
NCT06316960
Record updated
22 August 2024
Original description
The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.Read full original descriptionShow less

A Prospective, Multicenter Clinical Study on The Safety and Efficacy of Avapritinib in The Treatment of Relapsed/Refractory Pediatric Core Binding Factor Acute Myeloid Leukemia (CBF-AML) With KIT Mutation

The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.

Inclusion: Gender unlimited; Under 18 years; Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification); Presence of t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11; KIT mutation; Refractory AML: AML patients who do not achieve CR or CRi after induction therapy; Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration; No active infections; Liver function: Tbil ≤2×ULN, ALT/AST ≤3×ULN, creatinine clearance ≥50ml/min; ECOG score <2; Expected survival time >12 weeks; Participants must have the ability to understand and be willing to participate in this study and must sign an informed consent form.

Exclusion: Have received prior treatment with avapritinib; Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc; Presence of active uncontrolled infection (including bacterial, fungal, or viral infection); Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；; With other malignancies requiring treatment；; Already enrolled in another interventional clinical study；; The researchers determined that the individual is not suitable to participate in this trial.

ClinicalTrials.gov NCT06316960